FDA approves first RAS inhibitor for pancreatic cancer: daraxonrasib doubles survival

The US Food and Drug Administration on August 26 approved daraxonrasib, made by Revolution Medicines, for adults with metastatic pancreatic adenocarcinoma who have had at least one prior therapy. It is sold as Rasonque.

In the RASolute 302 trial of 500 patients, median overall survival was 13.2 months versus 6.7 months on chemotherapy, a 60 percent lower risk of death. Progression-free survival rose from 3.6 to 7.2 months, and tumours shrank in 30 percent of patients versus 11 percent on chemotherapy.

Why RAS matters

Mutations in the RAS gene family drive the great majority of pancreatic cancers and were long considered undruggable. The American Association for Cancer Research called it "the first pan-RAS inhibitor to be approved for any cancer type". The FDA acted about six and a half months ahead of its target date.